INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE

Superseded date

05-03-2013

Published date

01-12-2013

Publisher

Association Francaise de Normalisation

Avant-propos
1 Domaine d'application
2 Références normatives
3 Termes et définitions
4 Exigences relatives aux étiquettes
  4.1 Emballage externe
  4.2 Contenant primaire
5 Exigences relatives aux instructions d'utilisation
Annexe ZA (informative) Relation entre le présent document
                        et les Directives CE
Bibliographie

Defines the requirements for the information supplied by the manufacturer of in vitro diagnostic reagents that includes reagent products, calibrators, control materials and kits for professional use, hereafter called IVD reagents. Also applicable to accessories.

DevelopmentNote	Indice de classement: S92-010. (09/2002)
DocumentType	Standard
PublisherName	Association Francaise de Normalisation
Status	Superseded

Standards	Relationship
I.S. EN 375:2001	Identical
UNE-EN 375:2001	Identical
BS EN 375:2001	Identical
EN 375 : 2001	Identical
DIN EN 375:2001-06	Identical
UNI EN 375 : 2002	Identical

NF EN ISO 17511 : 2004	IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN BIOLOGICAL SAMPLES - METROLOGICAL TRACEABILITY OF VALUES ASSIGNED TO CALIBRATORS AND CONTROL MATERIALS
XP ENV 13607 : 2003 XP	HEALTH INFORMATICS - MESSAGES FOR THE EXCHANGE OF INFORMATION ON MEDICINE PRESCRIPTIONS